FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the mouse embryo assay (MEA) for assisted reproduction technology (ART) devices. Due to its legal nature, the document does not introduce mandatory rules and requirements the parties...
FDA
The Food and Drug Administration (FDA) has published guidance on the Breakthrough Devices Program, a special framework for medical devices intended to diagnose and treat severe diseases and life-threatening conditions. The document constitutes a final version of the...
FDA
The Food and Drug Administration (FDA) of the US has published an updated version of its guidance document dedicated to the coagulation systems for measurement of viscoelastic properties. The initial version of the guidance was published earlier on January 14, 2021....
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and healthcare products has published an action plan on Software as a Medical Device (SaMD) based on the Artificial Intelligence / Machine Learning (AI/ML)...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and healthcare products, has published detailed guidance dedicated to audits in the context of the Medical Device Single Audit Program (MDSAP). ...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices has published final guidance on labeling requirements for laparoscopic power morcellators. The present document constitutes a final version of the appropriate guidance...
